May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

The purpose of this Funding Opportunity Announcement (FOA)
issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA),
National Institutes of Health (NIH), is to encourage research grant
applications on screening and brief interventions to prevent and/or reduce
alcohol use and its adverse consequences.

This FOA is designed to stimulate a developmentally grounded
program of research on screening and brief interventions to prevent and/or
reduce underage drinking and hazardous young adult drinking. Research
objectives of this FOA include, but are not limited to: (1) testing strategies
to improve screening methods for youth with or at high risk for alcohol-related
problems; (2) testing the efficacy and effectiveness of novel or modified
evidence-based brief prevention interventions to: (a) prevent or delay the
initiation of alcohol use, or (b) decrease the risk for the development of
alcohol use disorders (AUDs) and associated problems among youth; (3) examining
individual, peer, familial, community, cultural, or other contextual factors
(e.g., health care settings) that affect the adoption, implementation, and
outcomes of empirically validated screening measures or brief interventions.
Studies of racially and ethnically diverse populations in various social and
cultural settings are encouraged. Investigations must be especially sensitive
to unique human subject issues when conducting research in minors.

Background

National surveys show that alcohol consumption is highly
prevalent among youth under age 21 and young adults, with 71% reporting use by
the end of high school (MTF, 2010). Underage drinking accounts for 16% of
alcohol sales and $62 billion in medical, social, and lost quality of life.
Among individuals ages 12 and older, 51.9% report being current drinkers
(NSDUH, 2009) and 24% report binge drinking (NSDUH, 2009; YRBSS, 2009). The
Monitoring the Future (2009) survey of college and young adult alcohol use
found that 37% of this population reported high rates of heavy (binge)
drinking. The typical age range for first development of alcohol dependence
is 18 to 24. Early onset of alcohol use and greater levels of binge drinking
during adolescence correlate strongly with the development of alcohol
dependence later in life. Compared to those who delay the onset of use until
age 21 or later, those who report beginning to drink at age 15 or younger are 4
times as likely to also describe drinking that is consistent with a diagnosis
of alcohol dependence at some point in their lives.

Drinking trajectories among youth vary and have been shown
to be characterized by amount and frequency of use, escalation patterns, and
age of drinking onset. Individual variables (e.g., age, race/ethnicity, puberty
and neurobiological maturation, individual, gender, temperament, poor
self-regulation, delinquency, intellectual abilities, negative affect,
psychiatric comorbidity, self-esteem, expectancies), familial factors (e.g.,
family history, genetic risk, parental monitoring, permissive attitudes), and
environmental factors (e.g., poverty, college/non-college, peer use, social
support, treatment for alcohol/drug problems) have all been implicated in the
variability in drinking patterns among underage drinkers and young adult
drinkers. According to national surveys (e.g., NESARC), gender disparities in
drinking patterns tend to emerge in older adolescence when males exhibit
greater frequency and quantity of alcohol consumption, although the gender gap
for alcohol consumption patterns is narrowing. In addition, some minorities
begin drinking at a later age and levels of consumption vary by gender as well
as by specific minority group. For example, although rates of alcohol use,
binge drinking, and AUDs have been shown to be greater among some American
Indian or Alaska Native adolescents, other American Indian groups are more
likely to abstain. Relative to the general population, lower levels of use are
reported among African Americans during youth, but higher percentages of heavy
and problematic use are reported in adulthood, particularly among males.

The period of adolescence through young adulthood is a
heterogeneous period of vulnerability during which developmental transitions
may differentially affect individuals. While underage drinking is associated
with substantial morbidity and mortality, age-related risk/protective factors
and differential consequences throughout pre-, middle, and late adolescence as
well as young adulthood have not been fully explored. Underage drinking is
multiply-determined and more research is needed to increase understanding of
the interplay of adolescent development, alcohol use, and prevention of
hazardous use and AUDs. A developmental approach to screening and prevention
interventions may: (1) optimally identify those with greater vulnerability and
critical periods of risk, (2) be more efficacious in minimizing risk and
altering drinking trajectories (i.e., delaying and/or preventing the initiation
and/or escalation of alcohol use, minimizing the risk for AUDs, promoting
long-term positive health outcomes) thereby reducing morbidity and mortality
among youth, and (3) assist in disentangling needs for universal versus
targeted approaches to screening and brief interventions dependent on
population and contextual features.

Screening

National and professional regulatory bodies (e.g., Surgeon
General’s Call to Action to Prevent and Reduce Underage Drinking, Substance
Abuse and Mental Health Services Administration, American College of Surgeons
Committee on Trauma, American Academy of Pediatrics, National Quality Forum)
have recommended screening and brief interventions in medical, educational, and
criminal justice settings to identify individuals at risk and reduce
alcohol-related harms. While the U.S. Preventive Services Task Force (2004)
recommended screening and behavioral counseling interventions to reduce alcohol
misuse by adults (in primary care settings), the evidence pro or con for
screening and providing brief interventions for adolescents in primary care was
determined to be inconclusive for efficacy and effectiveness. Underage drinking
is a significant public health problem that is associated with costs to
individuals and society, including intentional/unintentional injuries (e.g.,
motor vehicle crashes, suicide), violent crime, sexual assault, risky sexual
behavior, physical health effects (e.g., possible adverse effects on the
developing brain, alcohol poisoning), educational underachievement,
occupational and social consequences (e.g., deviant peer network), licit and
illicit drug use, and mental health problems. Early recognition and identification
of alcohol misuse among youth has potential to reduce alcohol-related harm. A
primary objective of screening is to identify individuals at risk for
alcohol-related problems but measurement methods must show sensitivity,
specificity, and have positive predictive value. Adolescents do not show the
same chronic effects of alcohol use (e.g., liver damage, cirrhosis) as older
adults do and less is known regarding their alcohol tolerance and sensitivity.
Thus, screening measures may need to consider a wider range of health behaviors
and adverse effects of alcohol exposure. Routine screening in a wide variety of
settings may be useful in identifying those at risk for AUDs and provide an
earlier entrée into developmentally appropriate and targeted interventions to
reduce underage drinking and development of AUDs. In addition, there is a need
for research that explores whether screening at an early age produces long term
benefits throughout the life course; for example, lower alcohol consumption
levels, reduced risk for AUDs, better overall health outcomes, etc.

Efforts to measure alcohol use among youth have included an
examination of consumption levels (e.g., age of onset and prevalence of current
or lifetime use; severity of use or hazardous use; concomitant substance use),
consequences of use (e.g., physical, social, psychological effects), and
diagnosis of alcohol abuse/dependence. Several measures have been
empirically-developed or applied to adolescents and young adult populations in
order to screen for hazardous use and/or alcohol-related problems; these
include but are not limited to the Adolescent Alcohol Involvement Scale (Mayer
& Filstead, 1979), Alcohol Use Disorders Identification Test (AUDIT; Babor
et al., 1992), CAGE (Ewing, 1984), CRAFFT (Knight et al., 1999), Customary
Drinking and Drug Use Record (CDDR; Brown et al., 1998), Drug Use Screening
Inventory (DUSI; Tarter, 1990), A-Obsessive Compulsive Drinking Scale (A-OCDS;
Deas et al., 2002), Personal Experience Screening Questionnaire (PESQ; Winters,
1992), Problem Oriented Screening Instrument for Teenagers (POSIT; Rahdert,
1991), RAFFT (Bastiaens et al., 2000), Rutgers Alcohol Problem Index (White
& Labouvie, 1989), Substance Abuse Subtle Screening Inventory-Adolescent
(SASSI-A; Miller, 1990; Miller & Lazowski, 2001), TWEAK (Russell, 1994),
and Youth Diagnostic Screening Test (Alibrandi, 1978). In addition, the NIAAA
developed a professional tool, Helping Patients Who Drink Too Much: A
Clinician's Guide (http://www.niaaa.nih.gov/Publications/EducationTrainingMaterials/Pages/guide.aspx)
to assist primary care and mental health clinicians in identifying individuals,
including adolescents, with or at risk for alcohol-related problems. However,
not all of these measures are sensitive in detecting alcohol misuse and related
problems in adolescents, some may require modifications of thresholds for
detection of use vs. diagnosis of problem drinking, and may not lend themselves
to examination of longitudinal transitions in patterns of alcohol use. Others
may not be transportable to all settings (e.g., schools, primary care, juvenile
detention centers) or populations (e.g., ethnic minorities) and do not fully
consider personality or temperamental traits that may pose a risk for the
development of alcohol involvement. Some studies, but not all, show that the
onset of alcohol use occurs during pre-adolescence with as many as 10% of youth
beginning to drink as early as ages 9 to 10. More research is needed that
evaluates screening and assessment measures that are developmentally
appropriate, practical, and psychometrically valid as well as tailored to high
risk and specific subpopulations (e.g., early adolescence, gender,
race/ethnicity, rural/urban, adolescents with psychiatric comorbidity) and
settings (e.g., schools, primary care, pediatric clinics, emergency/trauma
settings, mental health settings, work-place, juvenile courts, traffic courts).
Studies of barriers to screening (e.g., insurance and reimbursement issues,
parental involvement, health care provider attitudes, lack of provider time and
training, disincentives to reporting alcohol related injuries, large scale
implementation problems, setting implementation processes, cultural bias,
validation of self-report, other ethical issues) and evaluations of
implementation processes that promote positive outcomes are needed. It is
essential to establish psychometrically sound brief screening measures with high
sensitivity and specificity to detect underage risky drinking that are
effective across a variety of settings.

Examples of research that are encouraged by this FOA are
given below, and are not meant to be exclusive:

Studies that evaluate novel or modified
developmentally-matched, empirically-derived, screening instruments designed to
measure initiation of alcohol use, hazardous use, and the transition to AUDs.
More research is needed on: 1) the development of well-validated practical,
efficient and cost-effective screening tools; 2) the feasibility of
implementation of screening and setting-specific needs/barriers; and 3)
developmentally-matched screening instruments that characterize drinking
patterns and trajectories among youth that can be used to evaluate prevention
intervention outcomes or spontaneous recovery.

Studies that examine the linkage of alcohol screening with
other medical or health care services. More research is needed to evaluate how
screening can be effectively implemented in medical services where youth are
likely to seek access to care (e.g., primary care, pediatrician offices,
college health clinics, emergency rooms, mental health clinics) and how
implementation is affected by organizational, individual, and external (e.g.,
cultural, policy changes) factors.

Studies that examine alcohol screening in subpopulations.
More research is needed to evaluate optimal screening methods and settings to
target subpopulations among youth (e.g., females, pregnant women, ethnic
minorities, individuals with psychiatric comorbidity, individuals with other
drug-use comorbidity, individuals in criminal justice settings, individuals
with gay/lesbian/bisexual orientation, individuals with positive family history
of alcohol/other drug abuse or dependence), barriers to screening, and
programmatic features designed to reduce such impediments.

Studies that examine the roles of youth social networks,
schools, the workplace, community organizations (e.g., faith-based
organizations), and technological aids in screening and dissemination of
personalized or social norm feedback on the risks and consequences of hazardous
alcohol use.

Studies that examine the utility of screening for single
versus multiple licit/illicit drug use, other problem behaviors, or parental
drinking patterns/attitudes in identifying target populations for prevention
interventions.

Studies that assess whether adolescents and young adults are
willing to participate in screening programs and/or that seek to increase
participation.

Studies that examine the cost-effectiveness/cost-benefits of
screening to provide earlier identification of underage drinking and youth at
risk for AUDs and alcohol-related consequences.

Brief Interventions

Individuals who develop AUDs at younger ages are less likely
to seek alcohol-related treatment and are more likely to experience
chronic-relapsing alcohol disorders. Among adolescents approximately 10%
receive treatment; for college students, less than 5% of those with AUDs have
sought treatment. Earlier screening strategies and assessment of hazardous
drinking can be used to delay the onset and escalation of AUDs, identify risk
for AUDs, and classify individuals into developmentally-oriented or high risk
typologies, thereby improving referral to appropriate interventions to reduce
drinking and prevent AUDs.

Brief interventions have been implemented in a variety of
settings to reduce alcohol-related harm in youth; for example, emergency rooms,
primary care, school-based settings, and mass media. However, there are
inconsistent findings regarding their effectiveness across settings and some
locations (e.g., workplace, military settings) have not been fully explored.
Work has been associated with hazardous alcohol consumption and other risky
behaviors among youth, even when controlling for sociodemographic variables.
Work settings offer an underutilized community-level arena where prevention
interventions may be offered. In addition, research on brief interventions in
military populations (personnel and family) is needed.

Recent reviews indicate that brief interventions can be
effective in reducing alcohol use and alcohol-related consequences among
adolescents and young adults. However, no single brief intervention has been
reported to be effective across a wide range of populations and settings, and
there is no consensus about best practices for adolescent/young adult
interventions. Variable metrics used to determine effectiveness and breadth of
applicability (at the individual and/or setting levels) can affect estimates of
population impact of the intervention (Koepsell et al., 2011). Additionally,
even when interventions have been subjected to efficacy and effectiveness
trials, the transfer of evidence-based brief interventions into standard
practice is often delayed. Brief intervention studies to date have suffered
from limited outcome measurement, defined target population and measurement
inconsistencies, lack of standardization of the intervention (including poor
fidelity), variability in intensity and intervention goals, discordant
outcomes, modest effect sizes and minimal risk reductions, poor implementation,
and failure to fully examine implementation processes. Multidimensional
developmental models need to inform the design and implementation of prevention
interventions in light of the heterogeneity of adolescent populations and
multiple risk pathways that influence the development and resolution of AUDs.
Therefore, more research is needed to: (1) test the efficacy and effectiveness
of theoretically-based, empirically-derived, and developmentally appropriate
brief interventions, (2) test effective evidence-based interventions that
target specific subpopulations and settings, (3) distinguish core vs. adaptable
components of effective brief interventions, and (4) examine moderators and
mediators of the differential effectiveness of these brief interventions.
Greater understanding is required about the effects of the intervention
modality (e.g., brief vs. enhanced, narrow vs. multiple risk-behavior focus,
marketing strategy, parental/familial, in person vs. web/computerized,
individual vs. group-based, provider vs. peer-led, etc.) and intervention
enhancements (e.g., booster sessions, technological aids) on successful
outcomes. Examination of critical variables that contribute to more widespread
adoption and better translation of effective interventions into routine care
are necessary.

Examples of research that are encouraged by this FOA are
given below, and are not meant to be exclusive:

Studies that develop and test innovative brief
interventions, adapt existing brief interventions with demonstrated efficacy
for use in a variety of settings (e.g., schools, health care, juvenile justice,
military), or examine novel approaches to the implementation of brief interventions
in order to reduce risk for the development of AUDs. Work that examines
organizational (including setting-specific), individual, provider, and
intervention-related barriers to implementation is essential.

Studies that develop and test the efficacy of brief
interventions and study whether these effects are maintained longitudinally.
For example, are developmentally-targeted booster sessions needed to facilitate
the maintenance of long term effects? What is the impact on longer-term
morbidity and mortality?

Studies that evaluate the active ingredients of brief
intervention effects.

Studies that evaluate the role of associated problem
behaviors (e.g., psychiatric comorbidity, other drug use, violence, driving
under the influence, risky sex) on the effectiveness of brief interventions.

Studies that examine the integration of brief interventions
in routine health care and other public or private institutional settings
(e.g., primary care, mental health, emergency/trauma, and gynecologic/obstetric
care). What are the barriers to successful integration or implementation of
prevention interventions? What technological innovations, managerial practices,
or other strategies facilitate the implementation or adoption of prevention
interventions?

Studies that examine the cost-effectiveness/cost-benefits of
alternative approaches to providing brief interventions to reduce alcohol
consumption, risk for AUDs, and alcohol-related consequences.

Implementation studies that examine the translation of
evidence-based brief interventions into standard practice (e.g., college health
clinics, pediatric settings); studies that examine implementation processes and
contextual factors that hinder or facilitate adoption, sustainability, and the
effect of these on effectiveness outcomes.

Section II. Award Information

Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications.

Award Budget

Application budgets are not limited, but need to reflect
actual needs of the proposed project.

Award Project Period

1-5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424
(R&R) Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described
in the NIH
Grants Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before
submitting the application and follow the Policy on the Acceptance for Review
of Unsolicited Applications that Request $500,000 or More in Direct Costs as
described in the SF 424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD(s)/PI(s), do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate
the following additional items while determining scientific and technical
merit, and in providing an overall impact/priority score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their participation
according to the following five review criteria: 1) risk to subjects, 2)
adequacy of protection against risks, 3) potential benefits to the subjects and
others, 4) importance of the knowledge to be gained, and 5) data and safety
monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains, ages,
sex, and numbers to be used; 2) justifications for the use of animals and for
the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign
Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD(s)/PI(s) will be able to access his or her Summary Statement (written
critique) via the eRA Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.